Perceval Aortic Bioprostheses : Durability Study.

NCT ID: NCT07116265

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 192 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-01-01
• Study Completion Date: 2023-01-31

Brief Summary

Aortic valve replacement is one of the most commonly performed procedures in adult cardiac surgery in France.

Patients over the age of 65 most often receive a bioprosthetic aortic valve during an isolated aortic valve replacement or in combination with another cardiac surgery, which may extend the operative time.

The Perceval bioprosthesis has the advantage to reduce operative time due to its automatic deployment on a stent, which shortens the suturing time compared to other bioprostheses that require more sutures (sutureless valve).

In this retrospective, single-center, observational descriptive study, the investigators are conducting a follow-up of 193 patients operated on at the Montpellier University Hospital between January 2012 and January 2023, who received a Perceval aortic valve as part of routine annual follow-up, in order to assess the durability of this valve based on clinical and echocardiographic Valve Academic Research Consortium 3 (VARC-3) criteria.

Detailed Description

Exclusion Criteria :

Perceval bioprosthesis explanted during the same surgical procedure. History of aortic root surgery.

Primary Endpoint :

• Survival free from valve degeneration, according to VARC-3 criteria for structural or non-structural valve dysfunction.

Secondary endpoints :

• Freedom from aortic valve reintervention
• Freedom from SVD
• Freedom from permanent pacemaker implantation
• Freedom from stroke or transient ischemic attack
• Freedom from cardiac related rehospitalization
• Cardiac-specific mortality

Preoperative clinical data are collected via the DxCare electronic medical record system (including weight, height, medical history, and cardiovascular risk factors). Surgical data (type of procedure, operative time, outcomes at the end of surgery) are also extracted from the same software.

Follow-up Procedures :

Included patients are systematically scheduled for a cardiology follow-up consultation as part of routine annual postoperative care at the university hospital or in private practice. During this visit, they undergo a transthoracic echocardiography and a clinical assessment of their health status. These data are collected for analysis.

If patients are not followed up at the hospital and are considered lost to follow-up, their referring cardiologist will be contacted to obtain the most recent cardiological health data.

The annual follow-up echocardiography focuses on evaluating the hemodynamic parameters and durability of the bioprosthesis (presence or absence of pathological regurgitation, leaflet immobility, or thickening).

Clinical status is also assessed during the annual follow-up, including symptoms such as dyspnea, chest pain, and limitations in daily activities.

As part of standard follow-up, patients are contacted by phone and informed of the purpose of their scheduled visit to the Montpellier University Hospital.

For patients unable to attend an in-person consultation, a telephone interview is conducted to assess their clinical status, and their cardiologist is contacted to provide the most recent echocardiography report and clinical follow-up data. For patients who died before the beginning of the study, their trusted contact is approached to obtain clinical information regarding their medical history prior to death.

Conditions

Stenoses, Aortic Valve; Aortic Insufficiency; Aortic Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with severe or non-severe aortic stenosis, symptomatic or asymptomatic, who received a rapidly deployed Perceval aortic bioprosthesis between January 1, 2012, and January 31, 2023, in the cardiac surgery department at Montpellier University Hospital.

Exclusion Criteria

• Perceval bioprosthesis explanted during the same surgical procedure.
• History of aortic root surgery.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

31. Fischlein T, Meuris B, Hakim-Meibodi K, Misfeld M, Carrel T, Zembala M, et al. The sutureless aortic valve at 1 year: A large multicenter cohort study. JTCVS. (2016) ; 151(6):1617-1626.e4. 32. Fischlein T, Meuris B, Folliguet T, Hakim-Meibodi K, Misfeld M, Carrel T, et al. Midterm outcomes with a sutureless aortic bioprosthesis in a prospective multicenter cohort study. JTCVS. (2022) ; 164(6):1772-1780.e11. 35. Généreux P, Piazza N, Alu MC, Nazif T, Hahn RT, Pibarot P, et al. Valve Academic Research Consortium 3: Updated Endpoint Definitions for Aortic Valve Clinical Research. JACC. (2021) ; 77(21):2717-46.

Reference Type: BACKGROUND

Other Identifiers

IRB-MTP_2023_07_202301441

Identifier Type: -

Identifier Source: org_study_id